Olympus recalls certain endoscopes for potential infection risk due to water contamination in the channel after repair. Learn if your model is affected and what to do.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Olympus is recalling some endoscopes used for lower digestive tract procedures because water left in the channel after repair could cause infections. This risk occurs in a small percentage of scopes that were repaired and returned to customers.
Water remaining in the channel after repair can lead to contamination. This contamination may cause infections if the scope is used without proper cleaning. The risk is present in a small percentage of scopes that were repaired and returned to customers.
Patients who received the recalled endoscopes for procedures involving the lower digestive tract, such as the rectum or sigmoid colon. Healthcare providers using these specific models are most at risk.
Check for model number PCF-S (UDI-DI: PCF-S 04953170339912) on the endoscope. These scopes were sold for endoscopy and endoscopic surgery in the lower digestive tract, including the rectum and sigmoid colon.
Look for model number PCF-S (UDI-DI: PCF-S 04953170339912) on the endoscope.
No. This recall applies only to specific models with model number PCF-S (UDI-DI: PCF-S 04953170339912) used for lower digestive tract procedures.
The recall states that water remaining in the channel after repair could cause contamination, but there is no specific visual indicator mentioned in the record.
The recall record does not specify a remedy, so no action is required unless you have the specific model number mentioned.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0342-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0342-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.